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Leads medical device manufacturing process development, qualification, validation, transfer, scale-up, and continuous improvement. Resolves complex manufacturing issues, improves yield and process robustness, defines equipment and tooling requirements, and supports FDA QSR and ISO 13485 compliance. Provides technical leadership across manufacturing, quality, regulatory, supply chain, operations, and R&D while mentoring engineering and technical staff.

Leads the electrical engineering organization and governs electrical, firmware, and software system architecture for regulated cardiac medical devices. Responsibilities include developing technical leaders, managing architectural trade-offs, addressing technical debt, aligning documentation with ISO 13485 and QMSR, and collaborating across systems, firmware, software, mechanical, quality, regulatory, and program management teams.

Leads medical device product development from concept through design transfer, managing project plans, critical paths, technical risks, design controls, requirements, risk management, traceability, verification and validation, and design reviews. Applies mechanical or biomedical engineering expertise to optimize device performance, cost, manufacturability, and compliance. Coordinates cross-functional teams, supports pilot production and launch, resolves quality issues, manages suppliers and consultants, and mentors engineers and technicians.

Processes customer invoices and vendor bills; monitors accounts receivable, supports collections, resolves vendor invoice issues, and performs accounts payable activities. Assists with month-, quarter-, and year-end close, reconciliations, accruals, expense allocations, variance analysis, and audit support. The role is fully in-office five days per week in Santa Clara, California, with no supervisory responsibilities.